In the biopharmaceutical and pharmaceutical industries, product quality commences well before the last step of assembling the dosage form. It starts with checking the safety and efficacy of the raw materials and excipients. At Chromak Research Inc. (CRI), we provide fully pharmacopeial-compliant excipient and raw material testing services that guarantee regulatory compliance and protect the client’s investment during product development and manufacturing.
Why Raw Material Testing is Essential
Active ingredients, solvents, carriers, stabilizers, and other excipients are functional materials that contribute to the biological activity of a pharmaceutical product. Each of the pharmaceutical products must be accompanied by a well-documented and valid dossier following the guidelines set by ICH and FDA. Failure to do so may instigate a series of negative consequences, such as product recalls and regulatory fines for the manufacturer, coupled with adverse patient safety risks.
Every manufacturer avoids production delays, propelling Chromak Research to take preventative measures while ensuring each raw material’s compliance to specification exceed expectation. Our research team employs analytical procedures to verify every batch, while also avoiding costly stagnation by intercepting residues, particulates, extractables, and leachable in the production pipeline.
Excipient Testing. Why Does It Matter?
Although described as “inactive”, excipients play an incredibly important role in shaping a drug’s formulation, impacting everything from safety, effectiveness, patient compliance, and even a drug’s overall market viability. As such, testing them is imperative to guaranteeing quality, stability, and integrity throughout storage.
At Chromak, we offer comprehensive testing from all compendial excipient standards to client-specific protocols designed to surpass all regulatory expectations.
Regulatory-Compliant Testing Standards
As an established pharma laboratory, Chromak Research tests all raw materials and excipients against international pharmacopeial standards such as:
USP/NF (United States Pharmacopeia/National Formulary)
EP (European Pharmacopeia)
BP (British Pharmacopeia)
JP (Japanese Pharmacopeia)
ACS (American Chemical Society)
FCC (Food Chemicals Codex)
We also incorporate vendor-defined specifications and methods put forth by clients, offering limitless flexibility and customization for every test.
Our Raw Material & Excipient Testing Capabilities
Responsive to the various needs of the pharmaceutical industry, we provide a wide array of analytical services.
State-of-the-Art Laboratory Instrumentation
Chromak Research is fully equipped with modern analytical technologies for high-precision testing:
- Gas Chromatography (GC) – USP <621>
- Mass Spectrometry (MS) – USP <736>
- GC-MS and LC-MS
- High Performance Liquid Chromatography (HPLC) – USP <621>
- Thin Layer Chromatography (TLC) – USP <621>
- Infrared and FT-IR Spectroscopy – USP <197>
- Ion Chromatography (IC) – USP <1065>
pH, Conductivity, Viscosity, Loss on Drying (LOD), and Ignition (LOI) – USP <791>, <644>, <911>, <731>, <733>
With this extensive instrumentation suite, we can handle complex matrices, detect trace-level impurities, and ensure accurate and reliable results.
End-to-End Support for Method Development and Validation
In addition to compendial testing, Chromak Research provides services for:
- Method development tailored to unique materials
- Qualification and validation of analytical methods
- Method transfer and cross-validation across labs and analysts
- Batch release testing and vendor qualification support
Our expert team brings over 30 years of experience in analytical method development and regulatory compliance, ensuring the accuracy, reproducibility, and robustness of every result.
What Makes Chromak Research Inc. The Best Choice for You?
- Unmatched testing services for raw materials and excipients.
- Unconditional compliance with the FDA, ICH, and international Pharmacopeial guidelines.
- Quicker turnaround times of client-based method development.
- Uncompromised data integrity, master documentation, and audit preparedness.
- Unchanging emphases on confidentiality, accuracy, and scientific integrity.
Start with Us for Dependable RM and Excipient Testing
“Strives to start with quality at the source” precisely describes our mission here at Chromak Research. Sailings such as ‘Testing an excipient for a newly devised formulation’ or ‘qualifying a new vendor’, or ‘checking the supplied raw material before manufacturing’ become easily solvable with us as your trusted contract testing laboratory.
Reach out to us today and let us help you enhance your product development, regulatory submissions, or commercial manufacturing with confidence through our raw materials and excipient testing services.
